The present invention pertains to the medical field, and more particularly to a method and apparatus for counterpulsation therapy that can be used in treatment of cardiovascular disorders and in regenerative medicine as well.
Known in the art is a method of external aortal counterpulsation (Patent of Georgia GE 118), comprising transposing the skeletal muscle graft into a thoracic cavity and fixing it onto the aorta, and electric stimulation of the graft by means of electrodes in counterpulsation mode.
Also known is a method of non-invasive electric stimulation of a muscle (patent of Georgia GE 366) comprising affixing electrodes to the selected muscle, preliminarily determining cardiac rhythm and impacting by above-threshold electric pulses synchronized with the cardiac rhythm.
The mentioned method provides for the use of a cardioscope to choose the moment of the cardiac cycle in which the electrical impact has to be occurred, mostly in the counterpulsation mode (in diastole phase).
The problem related to the use of the above mentioned methods is that it is necessary to clearly identify T wave on an electrocardiogram tracing for the purposes of initiating the stimulation in diastole phase, because a time delay equal to Q-T interval needs to be defined by an operator.
To this end, the operator has to displace the electrodes of a single-channel sensor until the clear contours of R and T waves in an electrocardiogram tracing has been reached, or to use a 12-channel ECG device. Thereby the procedure becomes inconvenient and time-consuming.
In using the above mentioned methods, the stimulation may start in a wrong phase since the physiological deviation of the cardiac rhythm normally occurs (even in healthy humans), that is expressed in a cardiogram in the form of inequality of intervals R-R. In order to avoid this, the operator has to select the time delay of the stimulation so that the stimulation occurs at certain delayed time point after the T wave in a cardiogram so as to prevent the occurrence of stimulation in the systole phase that would inevitably have negative or even fatal effect on a patient's health.
Obviously, the effect of therapy in this event completely depends upon the operator's expertise and diligence. In the event of arrhythmia, the problem seems even more severe that could lead to a fatal result.
Known in the art are also a method and system for external counterpulsation therapy (application US 2009/0036938) wherein the system employs muscle stimulation transducers in order to stimulate skeletal muscle and/or vascular smooth muscle in synchronization with the cardiac cycle in a manner that increases the fluid pressure within veins and/or arteries during cardiac diastole.